Roadmap for and Policy in the United States

Executive Summary Kavita M. Berger1, Diane DiEuliis2, Corey Meyer1, and Venkat Rao3 1Gryphon Scientific, 2National Defense University, 3Parsons

SCIENTIFIC

This project was supported by a grant from the U.S. Air Force Academy and Defense Threat Reduction Agency under their Project on Advanced Systems and Concepts for Countering Weapons of Mass Destruction. Primary Investigator: Kavita M. Berger

ROADMAP FOR IMPEMENTING BIOSECURITY AND BIODEFENSE POLICY IN THE UNITED STATES

Project Partners Kavita M. Berger, Ph.D., Gryphon Scientific Diane DiEuliis, Ph.D., National Defense University Corey Meyer, Ph.D., Gryphon Scientific Venkat Rao, Ph.D., Parsons

Project Working Group: Dr. Ronald Atlas, University of Louisville Dr. Carole Baskin, Saint Louise University Rear Admiral Kenneth Bernard (ret.) Dr. Ellen Carlin, EcoHealth Alliance Dr. Sarah Carter, Science Policy Consulting Ms. Eleanor Celeste, Vertex Mr. Morgan Crafts, Northrop Grumman Dr. Julie Fischer, Georgetown University Dr. Matthew Frieman, University of Maryland Dr. Margaret Kosal, Georgia Institute of Technology Ms. Mary Beth Koza, University of North Carolina Dr. Tim Stearns, Stanford University Dr. Victoria Sutton, Texas Tech University Dr. Jennifer Weisman, Bill and Melinda Gates Foundation

Data Visualization: Dr. Emily Billings, Gryphon Scientific

Project Sponsor: U.S. Air Force Academy Projects on Advanced Systems and Concepts for Countering Weapons of Mass Destruction.

Acknowledgements: The project partners thank the U.S. Air Force Academy for supporting this project and all working group members for their contributions, insights, and peer review of all project methodologies, analyses, case studies, and final report. We thank all of the stakeholders with whom we spoke to ensure that the analyses and conclusions described in the report are accurate, relevant and appropriate. We thank U.S. government staff at the White House and Departments of Defense, State, Health and Human Services, and Agriculture, and Environmental Protection Agency for providing us opportunities to discuss our interim analyses. We thank the American Biological Safety Association, Association of Public Health Laboratories, American Society for Microbiology, Biotechnology Industry Organization, Engineering Biological Research Consortium, American Association for the Advancement of Science, Council on Government Relations, National Association of County and City Health Officials, and Association of State and Territorial Health Officials for helping us to engage their members during the course of the project.

Distribution Statement: Approved for public release. Distribution is unlimited.

The views and conclusions contained herein are those of the authors and should not be interpreted as necessarily representing the official policies and endorsements, either expressed or implied of the U.S. Air Force Academy, the U.S. government, or Parsons.

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Primary Investigator: Kavita M. Berger

Executive Summary The U.S. policy landscape for countering biological threats is split into two main groups: 1) biosecurity, which specifically focuses on preventing theft, diversion, or deliberate malicious use of biological sciences knowledge, skills, materials, and technologies to cause harm; and 2) biodefense, which involves the development of capabilities and knowledge-based to assess, detect, monitor, respond to, and attribute biological threats. Policies in both groups often affect the same stakeholders, which may result in mutual benefits among defense-oriented policies or counteract (or limit achievement of) defense and/or security objectives. Complicating the system for countering biological threats is the rapidly changing biotechnology landscape, which simultaneously presents new opportunities for building technological capabilities for defending against biological threats and for enabling security risks and vulnerabilities. As the U.S. government finalizes its new National Biodefense Strategy and begins preparing its Global Health Security Strategy, understanding the current policy landscape and the potential ability or inability of policies to achieve biodefense objectives is crucial to ensuring that the new strategies address long-standing gaps. Despite all of this activity in biodefense and biosecurity policy, systematic evaluation of existing policy and implementation to identify gaps and policy solutions for addressing those gaps has not been conducted, until now.

This report presents a roadmap for implementing biosecurity and biodefense policy to leverage the capabilities of science and technology advances and minimize security risks. Supporting the conclusions and suggestions in the Roadmap chapter are detailed analyses of the overall system of U.S. biosecurity and biodefense policy, existing methodologies for evaluating successful implementation of policies, and historical case studies with which to develop an analytic framework for assessing potential opportunity costs of biosecurity policy requirements. This study presents two analytic frameworks, one for developing and evaluating policy implementation and a second for examining direct costs, indirect effects arising from those costs, and their downstream consequences.

Changing Biotechnology Landscape Four primary changes have occurred during the past 10-15 years that have, and will continue to, alter the biotechnology landscape: 1) expansion of the funding landscape to include cross-over venture capital firms and public crowdsourcing in addition to private industry, philanthropic organizations, and government funders; 2) increasing convergence of physical, computational, materials, and life sciences; 3) broadening of practitioners of biology to include citizen scientists and non-life scientists and engineers; and 4) globalization of biotechnology capabilities. These changes are driven by many factors, including, but not limited to, social acceptance of health applications and increased agricultural needs. Together, these factors lead to transformative changes in biotechnology that enable new knowledge gain and new applications. Examples of biotechnologies that have altered current life science capabilities include precision medicine, systems-level analysis, bio-based systems for chemical production, synthetic biology, tissue printing, additive biomanufacturing, neural networks, and artificial 1 

Primary Investigator: Kavita M. Berger intelligence. Government and non-government funders have recognized the potential for these advances to improve health, agriculture, environmental monitoring, and energy.

Findings from Systems-based Evaluation of the Biosecurity and Biodefense Policy The systems-based policy analysis conducted in this study revealed several limitations of the current policy landscape and highlighted gaps in capabilities, implementation, and infrastructure. Limitations were identified in scope and relevance of policies, consistency of policy development and implementation, and in stakeholder engagement.

Priority Gaps and Consequences of the Limitations Gaps Consequences of the Limitations The need for greater investment, innovation, and The decreasing ability of the U.S. government to workforce development for microbial forensics. be a leader in scientific and technological advancement and application. The need to improve the input data for An inability to identify mutually-beneficial biosurveillance and early warning. policies, such as worker protection and laboratory biosafety, and counteracting policies, such as biodefense research investments and the Biological Select Agents and Toxins (BSAT) regulations. The need for greater attention to the security Difficulties of stakeholders to implement policies implications of scientific and technological with many mandated activities and little, or no, advances beyond those associated with pathogens financial support. and toxins. The lack of financial and technical resources to Challenges of local stakeholders to understand support local implementation of biosecurity their roles and responsibilities in implementing policies. biosecurity and biodefense policies. The continuously changing regulatory landscape for BSAT. Annual and inconsistent investments in nonproliferation activities, which can limit sustainability of activities. Effective measures for evaluating policy implementation and examining opportunity costs of new policies. The lack of programs for promoting resiliency within the research sector, including at the regional and national laboratories, despite the key role it plays in preventing, detecting, and assisting with response to biological threats.

In addition to these limitations and gaps, several key findings were observed from the policy analysis:  The U.S. biosecurity and biodefense policy landscape is a system of intersecting components, which can lead to mutually reinforcing policies or counteracting policies. Therefore, approaching U.S. policy development, analysis, and implementation in a systematic way enables more thorough understanding of the indirect costs, trade-offs, and feasibility of policies and their implementation. 2 

Primary Investigator: Kavita M. Berger

 No single strategy describes the full range of biosecurity and biodefense objectives of the U.S. Therefore, the U.S. biosecurity and biodefense enterprise would benefit from the development of a comprehensive, inclusive strategy that recognizes the interconnectedness of existing policy, depth of implementing and affected stakeholders, and outstanding gaps.  On occasion, local stakeholders voluntarily have developed and implemented policies and practices to address biosecurity and biosafety risks, and biodefense knowledge and technological gaps. These voluntary actions play a major role in risk reduction and capability building for the U.S.  Several barriers may prevent policies from being fully or adequately implemented, limiting their abilities to meet U.S. biodefense objectives. These barriers include counteracting policies, lack of support for compliance with high- burden requirements, and lack of cross-sectoral and cross-disciplinary stakeholder involvement in the policy development process.

System-wide Roadmap The roadmap for implementing biosecurity and biodefense policy addresses the identified limitations and gaps, builds on the key policy findings, and focuses on six primary actions that federal and local stakeholders have responsibility in implementing. The figure highlights the key elements of the roadmap.

Roadmap for implementing biosecurity and biodefense policy in the United States to leverage science and technology advances and simultaneously, minimize security risk.

Given the Department of Defense’s role in implementing biodefense and biosecurity policies more broadly, several of these actions apply to DoD.

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